An Open-Label Extension Study to Evaluate the Safety of the ForSight VISION5 Product

An Open-Label Extension (OLE) Study to Evaluate the Safety of the ForSight VISION5 Product in Subjects With Open-Angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-002

This study evaluates the long-term (13-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-002. All participants received Bimatoprost Ocular Insert and wore it for approximately 7 months, then had the Insert removed and a new insert placed for another 6 months.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma
• Intervention / Treatment: Drug: Bimatoprost

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Medical Research Center
    • La Jolla, California, United States, 92037
      • Scripps Clinic Torrey Pines
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Sacramento, California, United States, 95817
      • UC Davis Dept of Ophthalmology & Vision Science
  • Georgia
    • Atlanta, Georgia, United States, 30076
      • Coastal Research Associates
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
  • Missouri
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Consultants
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • UNC Kittner Eye Center
  • Ohio
    • Madeira, Ohio, United States, 45243
      • Apex Eye
  • Texas
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Completed FSV5-002 study.
2. Written informed consent prior to any study procedure.
3. Willingness to comply with the visit schedule.

Exclusion Criteria:

1. Participation in an investigational drug or device study other than FSV5-002 within the past 6 months or anticipated participation during the study period.
2. Subjects who will require contact lens use during the study period.
3. Any condition or situation (such as uncontrolled systemic disease) that, in the Investigator's opinion, might confound the results of the study, may put the subject at significant risk or might interfere with the subject's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13 mg Bimatoprost Ocular Insert; 13 mg Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new 13 mg Bimatoprost Ocular Insert and used continuously for another 6 months.	Drug: Bimatoprost; Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.; Other Names: "Lumigan" is the branded name of bimatoprost in eye drop form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity	An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.	13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Intraocular Pressure (IOP)	IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940].	Baseline (Day 1) to Month 13

Collaborators and Investigators

• Sponsor: ForSight Vision5, Inc.

Publications and helpful links

General Publications

• Brandt JD, DuBiner HB, Benza R, Sall KN, Walker GA, Semba CP; Collaborators. Long-term Safety and Efficacy of a Sustained-Release Bimatoprost Ocular Ring. Ophthalmology. 2017 Oct;124(10):1565-1566. doi: 10.1016/j.ophtha.2017.04.022. Epub 2017 May 17. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2014
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): January 31, 2016

Study Registration Dates

• First Submitted: May 18, 2014
• First Submitted That Met QC Criteria: May 18, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: FSV5-003